Comparison of tamsulosin vs. tamsulosin plus mirabegron in the management of overactive bladder in men with lower urinary tract symptoms

Efficacy and safety of tamsulosin vs. tamsulosin plus mirabegron in the management of overactive bladder in men with lower urinary tract symptoms

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/045280

Enrollment

100

Registered

2022-09-07

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

Interventions

Intervention1: Tamsulosin 0.4mg Mirabegrone 50mg: Tamsulosin 0.4mg at night daily for 8 weeks Mirabegrone 50mg at night daily for 8 weeks Control Intervention1: Tamsulosin 0.4mg Sporolac DS 1 Tab: Tam

Eligibility

Inclusion criteria

Inclusion criteria: newly diagnosed uncomplicated BPE of any size with predominant OABSS and an IPSS >7 without any medical contraindications to planned drug therapy or any absolute indication for surgery

Exclusion criteria

Exclusion criteria: history of anaphylaxis/ hypersensitivity, drug therapy with metabolic interference to administered medication, prostatic/urethral surgery and other concomitant prostate disease/ cancers, clinical neurological disorders and or neurogenic bladder

Design outcomes

Primary

Measure	Time frame
improvement in OABSSTimepoint: Day 0; After 8 weeks	—

Secondary

Measure	Time frame
improvement in IPSSTimepoint: Day 0; After 8 weeks	—

Countries

India

Contacts

Public ContactHarmandeep Singh Chahal

Dayanand Medical college and Hospital

drharmandeepchahal@yahoo.com9855999065

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026